Alcon constellation vision system инструкция на русском

OPERATOR’S MANUAL

Manufacturer: EU Authorized Representative:

Alcon Laboratories, Inc. Alcon Laboratories (U.K.) Ltd.

6201 South Freeway Boundary Way, Hemel Hempstead

Fort Worth, Texas 76134-2099 Hertfordshire, HP2 7UD England

U.S.A.

Produced By:

Alcon Laboratories, Inc.

15800 Alton Parkway

Irvine, California 92618-3818

U.S.A.

Telephone: 949/753-1393

800/832-7827

FAX: 949/753-6614

8065751025 Rev. P3, CATALOG NUMBER

905-2120-001 Rev. P3.1, TEXT ONLY © 2007 Alcon, Inc.

ii 8065751025

Constellation® Vision System

Constellation® Operator’s

8065751025

MANUAL REVISION RECORD

DATE REVISION ECN NUMBER AND DESCRIPTION

* Registered U.S. Patent & Trademark Office

9/15/06 P1

7/2/07 P2 (no PECN)

9/1807 P3

8065751025 iii

Constellation® Vision System

TABLE OF CONTENTS

TOPIC PAGE #

Manual Revision Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

Important Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

SECTION ONE — GENERAL INFORMATION

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

System Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7

Source Air Pressure Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7

Settings Restoration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7

Environmental Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8

User Information — Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8

Universal Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9

EMC Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9

FCC and IC Compliance Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12

EU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12

Australia and New Zealand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12

Cautions and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.13

Diathermy, Cautery, Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.18

Product Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.20

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.21

SECTION TWO — DESCRIPTION

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1

Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2

Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5

Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7

Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.8

Front Panel Displays And Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.12

Global Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.37

System State Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.41

Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.58

Surgical Modes And Submodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.65

End Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.94

Probes and Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.98

The Constellation Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.106

Consumable Pak Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.107

Combined Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.107

Posterior Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.108

Anterior Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.108

SECTION THREE — OPERATING INSTRUCTIONS

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Power Up Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1

Initial System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2

Constellation™ Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3

Procedure Pak and Cassette Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4

Posterior Segment Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5

Anterior Segment Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.6

Auto Gas Filler Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.8

Fragmentation Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.9

Viscous Fluid Control Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.10

Extrusion Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12

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Fiber Optic Illuminator Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12

Diathermy Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12

Pneumatic Handpiece Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.13

SECTION FOUR — CARE AND MAINTENANCE

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1

Upon Completion Of The Day’s Surgery Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2

Sterilization Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3

Reusable Handpiece and Accessories Cleaning and Sterilization Instruction . . . . . . . . . . . . . . . . . . . . . . . 4.4

Disposal of Xenon Lamps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8

SECTION FIVE — TROUBLESHOOTING

Equipment Malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1

System Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2

Advisory Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3

Information Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3

SECTION SIX — ACCESSORIES AND PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1

SECTION SEVEN — INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

TABLE OF CONTENTS

TOPIC PAGE #

8065751025 v

Constellation® Vision System

FIGURE # TITLE PAGE #

LIST OF ILLUSTRATIONS

Figure 1-1 The Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1

Figure 1-2 Icons used with the Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.5

Figure 1-3 Labeling used on the Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.6

Figure 1-4 Diathermy Power Through 75 Ohm Load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19

Figure 1-5 Diathermy Power Vs. Load Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19

Figure 1-6 Diathermy Output Voltage Vs. Output Control Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19

Figure 2-1 The Constellation® Vision System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.2

Figure 2-2 The Constellation® Vision System Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.5

Figure 2-3 The Constellation® Vision System Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.7

Figure 2-4 The Constellation® Vision System Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.8

Figure 2-5 Remote Control Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.10

Figure 2-6 Remote Control Channel Selection Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.11

Figure 2-7 The Startup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.12

Figure 2-8 The Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.13

Figure 2-9 The Main Screen Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.14

Figure 2-9a Procedure Modify Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.16

Figure 2-10 The Doctor Settings Popup — General Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.19

Figure 2-10a The Doctor Settings Popup — Surgery/Inf/Irr Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.20

Figure 2-10b The Doctor Settings Popup — Surgery/Reflux Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.21

Figure 2-10c The Doctor Settings Popup — Surgery/General Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.22

Figure 2-11 Doctor Settings — Footswitch Buttons Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.23

Figure 2-12 Footswitch Action Selection Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.24

Figure 2-13 Doctor Settings — Footswitch Treadle Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.25

Figure 2-14 Doctor Settings — Sound Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.26

Figure 2-15 Doctor Settings — Laser Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.27

Figure 2-16 Deleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.27

Figure 2-17 System Settings — Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.28

Figure 2-18 System Settings — Connections Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.29

Figure 2-19 System Settings — VideoOverlay Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.30

Figure 2-20 Auto Gas Fill Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.31

Figure 2-21 View/Copy/Delete Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.32

Figure 2-22 Sample View of a Doctor Settings Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.34

Figure 2-23 Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.35

Figure 2-24 About Constelllation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.35

Figure 2-25 Infusion Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.37

Figure 2-26 F/AX Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.38

Figure 2-27 Irrigation Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.39

Figure 2-28 Diathermy Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.39

Figure 2-29 Illuminator Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.40

Figure 2-30 The Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.41

Figure 2-31 The Fluidics Popup Screen(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.42

Figure 2-32 The Probe Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.43

Figure 2-33 The Handpiece Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.44

Figure 2-34 The Accessory Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.45

Figure 2-35 The Illuminator Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.46

Figure 2-36 The Laser Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.47

Figure 2-37 The Fluidics Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.49

Figure 2-38 The Detailed Probe Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.50

Figure 2-39 The Detailed Handpiece Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.51

Figure 2-40 The Detailed Accessory Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.52

Figure 2-41 The Detailed Illuminator Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.53

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Figure 2-41a The Detailed Laser Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.54

Figure 2-42 Video Help Popups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.55

Figure 2-43 Prime & Test Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.56

Figure 2-44 Consumables Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.56

Figure 2-45 Timer Configuration Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.57

Figure 2-46 The Surgery Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.58

Figure 2-47 Vacuum Control and Settings Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.59

Figure 2-48 Surgical Control Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.60

Figure 2-49 Surgical Control with Dropdown List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.61

Figure 2-50 Accurus® Classic Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.63

Figure 2-51 Surgical Step Panel — Custom Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.63

Figure 2-51a Surgical Step Panel Scroll Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.64

Figure 2-52 Surgery Screen: Vitrectomy Mode-3D Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.66

Figure 2-53 Surgery Screen: Vitrectomy Mode-Momentary Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.68

Figure 2-54 Surgery Screen: Vitrectomy Mode-PropVac Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.69

Figure 2-55 Surgery Screen: Vitrectomy Mode-VitWet Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.70

Figure 2-56 Surgery Screen: Phaco Mode — Burst Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.72

Figure 2-57 Surgery Screen: Phaco Mode — Custom Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.74

Figure 2-58 Surgery Screen: Phaco Mode — Pulsed Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.76

Figure 2-59 Surgery Screen: Phaco Mode — Continuous Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.78

Figure 2-60 Surgery Screen: Fragmentation Mode — Fixed Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.79

Figure 2-61 Surgery Screen: Fragmentation Mode — Linear Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.81

Figure 2-62 Surgery Screen: Fragmentation Mode — Momentary Submode . . . . . . . . . . . . . . . . . . . . . . . .2.82

Figure 2-63 Surgery Screen: Irrigation/Aspiration Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.83

Figure 2-64 Surgery Screen: Extrusion Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.85

Figure 2-65 Surgery Screen: Laser Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.87

Figure 2-66 Surgery Screen: Forceps Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.89

Figure 2-67 Surgery Screen: Scissors Mode — MultiCut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.90

Figure 2-68 Surgery Screen: Scissors Mode — Proportional . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.91

Figure 2-69 Surgery Screen: VFC Mode — Extract Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.92

Figure 2-70 Surgery Screen: VFC Mode — Injection Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.93

Figure 2-71 End Case Screen: Anterior Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.94

Figure 2-72 End Case: Setup Form Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.95

Figure 2-73 UltraVit Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.98

Figure 2-74 Pneumatic Scissors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.98

Figure 2-75 Fragmentation Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.99

Figure 2-76 Infiniti™* Ultrasonic (U/S) Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.99

Figure 2-77 TurboSonics® Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.101

Figure 2-78 Infiniti™* U/S Handpiece shown with Infusion Sleeve and Bubble Suppression Insert . . .2.102

Figure 2-79 Ultraflow™* IT handpiece and tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.104

Figure 2-80 Ultraflow™* IT handpiece with infusion sleeve, reusable I/A tip, and threaded tip adapter 2.104

Figure 2-81 Ultraflow™* O-ring tool with large and small O-rings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.104

Figure 2-82 Ultraflow™* SP handpiece (handpiece shown with .3 mm 45° tip) . . . . . . . . . . . . . . . . . . .2.104

Figure 2-83 Single use bipolar brush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.105

Figure 2-84 The Constellation® Combined Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.106

Figure 4-1. Auto Wash: Handpiece with «Y» Adapter Connected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6

Figure 4-2. Auto Wash: «Y» Adapter Connected to Injector Nozzel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6

Figure 4-3. Auto Wash: Unused Injectors Shown Plugged Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6

Figure 4-4. Depressurizing the Xenon Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.8

Figure 5-1 System Fault Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.1

Figure 5-2 System Error Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.2

Figure 5-3 Advisory Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.3

Figure 5-4 System Information Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.3

8065751025 vii

Constellation® Vision System

LIST OF TABLES

Table 1-1 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.2

Table 1-2 Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.4

Table 1-3 Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.10

Table 1-4 Recommended Separation Distances Between Portable and Mobile RF

Communications Equipment and the Constellation® Vision System . . . . . . . . . . . . . . . . . . .1.11

Table 2-1. Surgical Modes And Submodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.66

Table 6-1. Constellation® Vision System Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.1

TABLE # TITLE PAGE #

viii 8065751025

Constellation® Vision System

FOREWORD

This Operator’s Manual is designed to acquaint the operator and operating room personnel with

the Constellation® Vision System. The manual presents an organized summary of the operating

principles, main components, safety features, and instructions for care and use of the instrument.

The information in this manual should be supplemented with reference works on laser theory and the

interaction of laser energy with biologic tissues. No attempt is made in this manual to answer all the

questions that arise during the use of the instrument in medical procedures.

Questions concerning technique, safety and effectiveness should be referred to pertinent publications

or recognized medical experts in laser surgery. Physicians should not attempt to treat patients with

this instrument if not thoroughly familiar with its operation, or if in doubt as to its safe operation. All

personnel authorized to use this instrument should be required to be thoroughly familiar with this

manual.

Please contact Alcon for complete technical support and service if you have questions concerning any

aspect of this instrument’s operation or if it fails to perform satisfactorily.

To order supplies in U.S.A.:

800-862-5266

FAX: 800-241-0677

Outside U.S.A.: Contact your local Alcon representative for supplies.

8065751025 ix

Constellation® Vision System

IMPORTANT NOTICE

Equipment improvement is an on-going process and, as such, changes may be made to the equipment

after this manual is printed.

Pay close attention to WARNINGS and CAUTIONS in this manual. WARNINGS are written to

protect individuals from bodily harm. CAUTIONS are written to protect the instrument from damage.

Illustrations contained in this manual are for reference only.

It is recommended that maintenance be performed by a qualified Alcon Field Engineer.

Alcon Surgical shall not be liable for any damage resulting from failure to comply with the enclosed

instructions.

Alcon reserves the right to change specifications without further notice.

Operator Profile

The Constellation Vision System is designed to be operated by two basic groups; surgeons and

nurses/scrub techs. The surgeon focus is primarily constrained to the footswitch and display panel.

The design of the footswitch allows the surgeon to map any function to any switch position,

assuming the function is valid in a particular scenario. The display screen was designed to mount

on an articulating arm to allow optimum placement of the display so the surgeon can reference it at

any time. The design also incorporated items specifically for nurses and scrub techs, who routinely

control the machine via the front panel and remote control. The design incorporates color coding on

all connectors and tubing to facilitate easy identification of the ports. In addition, the graphical user

interface closely resembles controls commonly found on web sites, which this operator profile is

expected to be highly proficient at using.

CAUTION

U.S. Federal Law restricts this device to sale by or on the order of a physician only.

WARNINGS!

For systems containing the optional laser module: Use of controls or adjustments, or

performance of procedures other than those specified herein may result in hazardous

laser radiation exposure.

A qualified technician must perform a visual inspection of the following components

every twelve months. In case of a deficiency, do not use the system; call Alcon Technical

Services.

— Warning Labels

— Power Cord

— Fuses

A qualified technician must check ground continuity and both polarities for leakage

current every twelve months to ensure they are within the applicable standard (for

example: EN 60601-1/IEC 601-1). Values must be recorded, and if they are above the

applicable standard, or 50% above your first measurement, do not use the system; call

Alcon Technical Services.

Use of accessories and cables other than those provided may result in increased

emissions or decreased immunity of the system. Portable and mobile RF

communications equipment can affect this medical electrical equipment.

x 8065751025

Constellation® Vision System

LAST PAGE OF THIS SECTION

Comments or corrections concerning this manual should be addressed to:

Alcon

Technical Services Group

PO BOX 19587

Irvine, CA, USA 92623

All rights reserved. No part of this manual may be reproduced, transmitted, or stored in a retrieval

system, in any form or by any means; photocopying, electronic, mechanical, recording, or otherwise;

without prior written permission from Alcon Laboratories, Inc.

8065751025 1.1

Constellation® Vision System

SECTION ONE

GENERAL INFORMATION

Introduction

The Constellation® Vision System is a multifunctional surgical tool for use in anterior

and posterior segment ophthalmic surgeries. The product’s capabilities include

driving a variety of handpieces that provide the ability to cut vitreous and tissues,

emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to

stop bleeding. Vacuum is used to remove ocular matter from the eye and is provided

by connecting tubing from the handpiece to a port on the fluidics cassette. Irrigation/

infusion capability is provided to replace fluid in the eye, and enters the eye directly

via either an infusion cannula or flows through a handpiece. The graphical operator

interface is menu driven. The operator provides inputs using the touchscreen panel,

the remote control, voice commands, and the footswitch.

Figure 1-1 The Constellation® Vision System — The Constellation® Vision System is

a multifunctional surgical tool is used in anterior and posterior segment

ophthalmic surgeries.

1.2 8065751025

Constellation® Vision System

CONSOLE

DIMENSIONS:

Tabletop:

Height: 160.0 cm (63.0 inches)

Width: 76.2 cm (30.0 inches)

Depth: 77.5 cm (30.5 inches)

Base:

Height: 63.5 cm (25.0 inches)

Width: 53.3 cm (21.0 inches)

Depth: 57.2 cm (22.5 inches)

WEIGHT:

Tabletop: 61.2 kg (135 pounds)

Base: 72.6 kg (160 pounds)

ENVIRONMENTAL LIMITATIONS:

Operating Non-Operating

Altitude: -125 to 2000 m -125 to 3000 m

(-410 to 6562 feet) (-410 to 9843 feet)

Temperature: 10° C to 35° C -10 to 55°C

(50° F to 95° F) (14° F to 131° F)

Relative Humidity: 10% to 95% 10% to 95%

without without

condensation condensation

ELECTRICAL REQUIREMENTS: The console accepts the following

ranges or input commercial power voltages and frequencies and meets

the leakage currents specified in IEC 60601-1. Protection against electrical

shock is Class I.

100-120 Vac 50/60 Hz 12 A max. Fuse: T 10 A / 250 V slow blow

220-240 Vac 50/60 Hz 7.5 A max. Fuse: T 5 A / 250 V slow blow

FOOTSWITCH

DIMENSIONS:

Height: 14.0 cm (5.50 inches)

Width: 22.9 cm (9.00 inches)

Depth: 43.2 cm (17.0 inches)

WEIGHT: 5.4 kg (12 pounds)

ENVIRONMENTAL: The footswitch construction is water tight in

compliance with IEC 60601-1 and IEC 60601-2-2, subclause 44.6 aa.

ELECTRICAL: The footswitch is connected to the console via electrical

cable.

All power and communications enter/exit the footswitch from this

cable.

Table 1-1 CONSTELLATION® VISION SYSTEM SPECIFICATIONS — This table is a quick reference point to

identify system specifications, system requirements, and performance figures.

PERFORMANCE SPECIFICATIONS

PRESSURIZED INFUSION/IRRIGATION @SEA LEVEL:

Range: 0 to 120 mmHg

Accuracy: ±(2% of setpoint +5 mmHg)

Flow Rate: 0 — 20 cc/min. for infusion (20 Ga)

0 — 60 cc/min. for irrigation

Setpoint Transient: 500 ms maximum

IOP CONTROLLED INFUSION:

Setpoint Range: 0-120 mmHg

Repeatability1: ± 2 mmHg2

Setpoint Response Time: <500 ms (20 Ga)

Transient Disturbance

Response Time: <500 ms3

Flow Range: 0-20 cc/min

1 BSS Dual chamber mode.

2 BSS medium, 20 gauge high flow Cannula, steady state condition

at rated flow range

3 Transient condition from no flow state to 10cc/min

ASPIRATION/SUCTION @SEA LEVEL:

Standard & Reduced

Pressure Range: 0-650 mmHg Vacuum

Minimal Pressure Range: 0-600 mmHg Vacuum

Pressure Accuracy: ±(2% of Setpoint +5 mmHg)

Flow Range:

Posterior Modalities: 0-20 cc/min

Anterior Modalities: 0-60 cc/min

Transient Response Time

(Standard Pressure Range): From– 0 to -400 mmHg @0 cc/min

10-90% Rise Time:300 msec max

90-10% Fall Time: 300 msec max

IRRIGATION/ASPIRATION @SEA LEVEL:

Sub Modes: Cap Vac, I/A Max

Vacuum:

Standard & Reduced

Pressure Range: 0 to -650 mmHg

Minimal Pressure Range: 0 to -600 mmHg Vacuum

Vacuum Accuracy: 2% of displayed value + 5

mmHg

Flow Rate: 10 cc/min minimum + 1.5cc at

50 mmHg vacuum max

VACUUM @ SEA LEVEL:

Vitrectomy: 0 to 650 mmHg

Fragmentation: 0 to 650 mmHg

Extrusion: 0 to 650 mmHg

Extraction: 0 to 650 mmHg

Irrigation/Aspiration: 0 to 650 mmHg

Phacoemulsification: 0 to 650 mmHg

8065751025 1.3

Constellation® Vision System

PERFORMANCE SPECIFICATIONS…continued

LOW PRESSURE AIR SOURCE (LPAS) @SEA LEVEL:

Pressure Range: 0 – 120 mmHg at rated flow

Pressure Accuracy: ±3% of Setpoint +3 mmHg

Flow Rate: 1.2 slpm minimum at 120 mmHg

VITRECTOMY:

Submodes: 3D, Momentary, PropVac, VitWet

Cut Rate:

UltraVit™ 5000 Probe: 100 to 5000 cpm

UltraVit™ 2500 Probe: 100 to 2500 cpm

DIATHERMY:

Frequency: 1.5 Mhz ± 10%.

Waveshape: Sinusoidal

Output power 10 Watts maximum at 100% setting

with 75 ± 10% ohm non-inductive load

Power range 0 — 100% of maximum output power

ILLUMINATION:

Lumen Accuracy: ±30%

Light Output through 20GA 0.5

NA Fiber Probe: 0-200 hrs: 50 lumens minimum

at 100% setting

201-400 hrs:25 lumens minimum

at 100% setting

Light Output through

25GA 0.63 NA Fiber Probe: 0-200 hrs: 15 lumens minimum

at 100% setting

201-400 hrs:10 lumens minimum

at 100% setting

FRAGMENTATION:

Submodes: Linear, Fixed, Momentary

Tip Stroke @ 100%: 3.1 ± 0.5 mils at 100% power

Resonant Frequency: 39.0 ± 1.9 KHz

Pulse Rate Range: 0 – 100 pps

SCISSORS:

Submodes: Proportional, Multi-Cut

Proportional Pressure: 0-50 psi @sea level

Multi Cut Rate: single cut to 450 cpm

PROPORTIONAL AND CONTINUOUS REFLUX @SEA LEVEL:

Pressure Range: 0 to 120 mmHg

Pressure Accuracy: ±(2% of Setpoint +5 mmHg)

MICRO REFLUX:

Pressure Range: 100 ± 15% mmHg1

Volume: 50 ± 10 µL1

1 measured with unoccluded Accurus® probe and aspiration tubing

VISCOUS FLUID CONTROL:

Submodes: Inject, Dual, Extract

Injection Pressure: 0 to 551.6 KPascal (0 to 80 psi)

0 to 482.7 KPascal

@ Reduced (0 to 70 psi)

Extract Vacuum

at Sea Level:

0 to 650 mmHg

Table 1-1 CONSTELLATION® VISION SYSTEM SPECIFICATIONS…continued

AUTO-GAS FILLING (AGF):

Maximum Gas Pressure: 10 psig

Fill Purity: 99.9% gas concentration

following fill

AUTO-STOPCOCK:

Response Time: 0.5 seconds minimum

Pressure (Liquid): 0-120 mmHg

Rated Flow (Liquid): 20 cc/min

Pressure (LPAS): 0-120 mmHg

Rated Flow (LPAS): 1.2 slpm

PHACOEMULSIFICATION:

Submodes: Burst, Pulsed, Continuous

Tip Stroke @ 100%: 3.5 ± 0.5 mils

Resonant Frequency: 34khz – 42Khz ± 10%.

Pulse Rate Range: 0-100 pulses per second

Burst Length: 2.5 sec – user adjustable

Burst Pulse durations: 5ms to 500ms

ANTERIOR VITRECTOMY:

Submodes: Wet, Dry

Cut Rate: 0 to probe maximum

LASER (optional):

Treatment beam:

Class: IV

Power: 30 mW to 2 W (maximum)

Wavelength: 532 nm

Aiming beam:

Class: II

Power: less than 1mW

Wavelength: 635 nm ± 5 nm

DOCTOR MEMORIES:

Storage Capacity: xxx Doctors

Memory Cells per Dr: xx (xx anterior, xx posterior, xx common)

TIMER:

Range: 0 to xx h

Resolution: 1 s

TONE VOLUMES @ 1 Meter:

Errors/Faults/Invalid Key: 40 to 65 dB, short tones

Diathermy: 40 to 65 dB, continuous tone

Advisory/Timer Expire/Elev Infusion: 0 to 65 dB, short tones

Frag/Phaco/Vacuum: 0 to 65 dB, continuous tone

Valid Key: Factory set and not adjustable

Volume Accuracy: 6 dB

VOICE CONFIRMATION: 0 to 65 dB

REMOTE CONTROL:

Method: Infrared

Channels: 4

1.4 8065751025

Constellation® Vision System

Term or Abbreviation

BSS PLUS®

cmH2O

cpm

Detent

Diathermy

Extrusion

F/AX

Frag

Global Function

Highlighted

I/A

IEC

ISO

IV

LCD

mmHg

N/A

PEL

PIN

psi

pps

slpm

U/S

VFC

Vit

Description

Balanced Salt Solution enriched with bicarbonate, dextrose, and glutathione.

Centimeters of water.

Cuts Per Minute.

A discrete footpedal position at which more force is required to depress the footpedal to

the next position.

The production of heat in body tissues by electric current for therapeutic purposes.

A mode where vacuum is available to remove fluid/matter.

Fluid Air Exchange.

Fragmentation.

A function whose status and controls are independent of the current footpedal position

and surgery mode.

To center attention by video reversing the function key and changing the key color from

gray to blue.

Irrigation/Aspiration.

International Electromechanical Commission.

International Standards Organization.

Intravenous.

Liquid Crystal Display.

Millimeter of Mercury. A unit of vacuum.

Not Applicable.

Patient Eye Level. A difference in height between the cassette and the patient eye level.

Personal Identification Number.

Pressure per Square Inch. A unit of pressure.

Pulses Per Second.

Standard Liters Per Minute.

Ultrasound.

Viscous Fluid Control.

Vitrectomy. Extraction of the vitreous from the vitreous cavity.

Table 1-2 Terms and Abbreviations

8065751025 1.5

Constellation® Vision System

Figure 1-2 ICONS USED WITH THE Constellation® Vision System — Icons identifying modes, functions, etc., that

are used with the Constellation® Vision System are identified in this chart.

Extrusion

Forceps

Fragmentation

Irrigation/

Aspiration

Laser

Phaco

Scissors

Viscous

Fluid

Control

(VFC)

Vitrectomy

Expand

Window

Help Video

Modify

Power

Save

Air Pressure

Input

Auto Gas Filling

(AGF)

Alternating

Current

Coagulation

Connector

Connection

Indicator

Dangerous

Voltage

Eject

Equipotentiality

Footswitch

Forceps

Fuse

Hot

Illuminator

Laser

Connection

Laser

Emergency Stop

Switch

Laser Port 1

Tethered Laser

Network

Connection

Off

On

Consult

Operator’s

Manual, or

System Error or

Advisory

Opens

Operator’s

Manual

Video Recorder

Scissors

Connector

Serial In/Out

Standby State

System Fault

System

Information

Type BF

Equipment

Type B

Equipment

U/S Handpiece

Connector

USB Connector

Use appropriate

take-back

system (see

Environmental

Considerations in

this manual).

Viscous

Fluid Control

Connector

VGA Out

Video In/Out

Vitreous Cutter

Connection

1.6 8065751025

Constellation® Vision System

Figure 1-3 LABELING USED ON THE CONSTELLATION® VISION SYSTEM — Labels used on the Constellation®

Vision System console are identified and illustrated here.

Labels for gas containers

8065751025 1.7

Constellation® Vision System

System Installation

In the USA contact the Alcon Technical Services Department for uncrating and

installation at (800) 832-7827. Outside the USA contact your local Alcon affiliate.

Source Air Pressure Requirements

The Constellation® Vision System

is designed to operate using different levels of

source air pressure. The system operates automatically with pressures of 58 (4 bar) to

120 psi (8.3 bar). Between 4 bar and 5 bar, vacuum performance is reduced. Between

4 bar and 5.5 bar, VFC inject performance is reduced.

Accessory equipment connected to or used with this equipment must be certified

according to the respective IEC Standard (e.g., IEC 60950 for data processing

equipment, and IEC 60601-1 for medical equipment). The Constellation® is shipped

with English and metric air fittings compliant with EN739:1998. Anyone connecting

additional equipment or otherwise causing a different system configuration than

provided by Alcon is responsible for continued compliance to the requirements

of System Standard IEC 60601-1-1. If in doubt, consult the Technical Services

department or your local Alcon representative.

Settings Restoration

When a loss of power occurs, the Constellation® Vision System retains its current

settings and mode in memory. When power is reestablished a System Information

popup window appears asking:

«Do you want to restore the system’s previous settings and mode?»

The user can press Yes to restore the previous settings, or No to enter the default

settings. Disconnecting the power cord, or turning the system off using the rear panel

power switch, is considered a loss of power; using the rear panel standby switch is

not.

1.8 8065751025

Constellation® Vision System

Environmental Issues

Follow local governing ordinances and recycling plans regarding disposal or

recycling of device components.

WARNINGS!

Laser: There are potential hazards when inserting, steeply bending, or improperly

securing the fiberoptic. Not following the recommendations of the manufacturer

may lead to damage of the fiber or delivery system and/or harm to the patient or

user.

Since the aiming beam passes down the same delivery system as the treatment

beam, it provides a good method of checking the integrity of the delivery system.

If the aiming beam spot is not present at the distal end of the delivery system,

or its intensity is reduced or it looks diffused, this a possible indication of a

damaged or not properly working delivery system. If there is any doubt, contact

Alcon Technical Services.

The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O)

and oxygen should be avoided. Some materials — for example cotton wool when

saturated with oxygen — may be ignited by the high temperatures produced in normal

use of the laser equipment. The solvents of adhesives and flammable solutions

used for cleaning and disinfecting should be allowed to evaporate before the laser

equipment is used. There is also danger of ignition of endogenous gases.

User Information — Environmental Considerations

The equipment that you have purchased requires the use of natural resources for its

production. This equipment may also contain hazardous substances which could have

potential effect on the environment and human health if disposed of improperly.

In order to avoid the entry of any such substances into our environment and to

promote natural resource conservation, we encourage you to use the appropriate take-

back systems. Such take-back systems reuse or recycle many of the materials in your

end-of-life equipment in a beneficial way. Please contact your local Alcon office for

assistance in take-back options through Alcon or other providers.

The crossed-bin symbol located on this equipment reminds you to use take-back

systems, while also emphasizing the requirement to collect waste equipment

separately, and not dispose of it as unsorted municipal waste.

If you need more information on the collection, reuse or recycle systems available to

you, please contact your local or regional waste administration, or contact your local

Alcon office for more information.

8065751025 1.9

Constellation® Vision System

Universal Precautions

Universal precautions shall be observed by all people who come in contact with the

instrument and/or accessories to help prevent their exposure to blood-borne pathogens

and/or other potentially infectious materials. In any circumstance, wherein the exact

status of blood or body fluids/tissues encountered are unknown, it shall be uniformly

considered potentially infectious and handled in accordance with OSHA guidelines.

EMC Statement

It is important to install and use the equipment in accordance with the instructions

in order to prevent harmful interference with other devices in the vicinity. If this

equipment causes harmful interference to other devices (determined by turning the

equipment off and on), the user is encouraged to try to correct the interference by one

or more of the following measures:

Reorient or relocate the other device(s).

• Increase the distance between the equipment.

• Connect this equipment into an outlet on a circuit different from that to which the

other device(s) is connected.

• Consult the manufacturer or your Alcon field service engineer for help.

Table 1-2 Guidance and Manufacturer’s Declaration — Electromagnetic Emissions — The Constellation®

Vision System is intended for use in the electromagnetic environment specified below. The

customer or the user of the system should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment-Guidance

RF emissions

CISPR 11

Group 1 The Constellation® Vision System uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause any interference

in nearby electronic equipment.

RF emissions

CISPR 11

Class A Based on extensive field experience the Constellation® Vision System is suitable

for use in all establishments other than domestic and those directly connected

to the public low voltage power supply network that supplies buildings used for

domestic purposes.

The EMC Statement provides guidance on steps to take in case of electromagnetic

interference.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

Flicker emissions

IEC 61000-3-3

Complies

1.10 8065751025

Constellation® Vision System

Table 1-3 Guidance and Manufacturer’s Declaration — Electromagnetic Immunity — The Constellation®

Vision System is intended for use in the electromagnetic environment specified below. The

customer or the user of the Constellation® Vision System should assure that it is used in

such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment-Guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

• ±6 kV contact

• ±8 kV air • ±6 kV contact

• ±8 kV air

Floors should be wood, concrete, or ceramic tile. Do

not use around floors that are covered with synthetic

material to avoid laser stoppage due to ESD.

Electrical fast

transient/burst

IEC 61000-4-4

• ±2 kV for power

supply lines

• ±1 kV for input/output

lines

• ±2 kV for power

supply lines

• ±1 kV for input/

output lines

Mains power quality should be that of a typical

commercial or hospital environment. To avoid laser

stoppage due to fast transients avoid powering the

Constellation® Vision System on the same branch

circuit with sources that can generate fast transients

(inductive switching; e.g., high current motors).

Surge

IEC 61000-4-5 • ±1 kV differential

mode

• ±2 kV common mode

• ±1 kV differential

mode

• ±2 kV common

mode

Mains power quality should be that of a typical

commercial or hospital environment. To avoid

laser stoppage due to power-line surges consider

powering the Constellation® Vision System through

branch circuit that has surge suppressor for

protection against lightning surges (e.g., at power

panel to surgical/office suite).

Voltage dips, short

interruptions, and

voltage variations

on power supply

input lines

IEC 61000-4-11

• <5% UT (>95% dip in

UT) for 0.5 cycle

• 40% UT (60% dip in

UT) for 5 cycles

• 70% (30% dip in UT)

for 25 cycles

• <5% (>95% dip in

UT) for 5 sec

• <5% UT (>95% dip

in UT) for 0.5 cycle

• 40% UT (60% dip

in UT) for 5 cycles

• 70% (30% dip in

UT) for 25 cycles

• <5% (>95% dip in

UT) for 5 sec

Mains power quality should be that of a typical

commercial or hospital environment. If the uses of

the Constellation® Vision System require continued

operation during power mains interruptions, it is

recommended that the Constellation® Vision System

be powered from an uninterruptible power supply

or a battery.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at

levels characteristic of a typical location in a typical

commercial or hospital environment.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 Vrms

3V/m

Portable and mobile RF communications equipment

should be used no closer to any part of the

Constellation® Vision System, including cables, than

the recommended separation distance calculated

from the equation applicable to the frequency to

the transmitter.

Recommended separation distance:

d = 1.2√P

d = 1.2√P 80 MHz to 800 MHz

d = 2.3√P 800 MHz to 2.5 GHz

Constellation® Vision System

where P is the maximum output power rating to the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation

distance in meters (m).

Field strength from fixed RF transmitters, as

determined by an electromagnetic site surveya,

should be less than the compliance level in each

frequency rangeb.

Interference may occur in the vicinity of

equipment marked with following symbol.

Note: UT is the a.c. mains voltage prior to application of the test level.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from

structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) and land mobile radios, amateur radio, AM and

FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment

due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in

which the Constellation® Vision System is used exceeds the applicable RF compliance level above, the Constellation® Vision

System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,

such as re-orienting or relocating the Constellation® Vision System.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

8065751025 1.11

Constellation® Vision System

Table 1-4 Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the Constellation® Vision System — The Constellation® Vision System is

intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of the Constellation® Vision System can help prevent

electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the Constellation® Vision System

as recommended below, according to the maximum output power of the communications

equipment.

Separation distance according to frequency of transmitter

(m)

Rated maximum output

power of transmitter

(W)

150 kHz to 80 MHz

d = 1.2√P

80 MHz to 800 MHz

d = 1.2√P

800 MHz to 2.5 GHz

d = 2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rates at a maximum output power not listed above, the recommended separation distance d in meters (m) can

be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter manufacturer.

Note 1 — At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2 — These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from

structures, objects, and people.

1.12 8065751025

Constellation® Vision System

USA – Federal Communications Commission (FCC) Compliance Statement

This device complies with Part 15 of the FCC Rules. Operation is subject to the

following two conditions:

This device may not cause harmful interference.

This device must accept any interference received, including interference that may

cause undesired operation.

Caution

Change or modifications made to this equipment not expressly approved by Alcon

may void the FCC authorization to operate this equipment.

FCC Radiation Exposure Statement

Caution

To ensure that the radio transmitter complies with current FCC regulations limiting

both maximum output RF power and human exposure to radio frequency radiation, a

separate distance of at least 20 cm must be maintained between the unit’s antenna and

the body of the user and any nearby persons at all times, and unit’s antenna must not

be co-located or operating in conjunction with any other antenna or transmitter.

Canada – Industry of Canada (IC) Compliance Statement

This device complies with Industry Canada Radio Standards Specification RSS-210.

Operation is subject to the following two conditions:

This device may not cause harmful interference

This device must accept any interference, including interference that may cause

undesired operation of the device.

This ISM device complies with Canadian ICES-001.

Cet appareil ISM est conforme à la norme NMB-001 du Canada.

Antenna Notices

This device has been designed to operate with the antenna having a maximum gain of

5 dBi. Antenna having a gain greater than 5 dBi is strictly prohibited for use with this

device. The required antenna impedance is 50 ohms.

To reduce potential radio interference to other users, the antenna type and its gain

should be so chosen that the equivalent isotropically radiated power (EIRP) is not

more than that required for successful communication.

Exposure of Humans to RF Fields

This device complies with the RF exposure limits for humans as called out in RSS-

102.

1.

2.

1.

2.

8065751025 1.13

Constellation® Vision System

Europe – R&TTE Directive 99/5/EC

This device complies with the requirements of the Council Directive 99/5/EC

(R&TTE).

Caution

The radio equipment is intended to be used in all EU and AFTA countries. Outdoor use

may be restricted to certain frequencies and/or may require a license for operation.

Contact local Authority for procedure to follow.

Note: Combinations of power levels and antennas resulting in a radiated power

of above 100mW equivalent isotropic radiated power (e.i.r.p) are considered as

not compliant with the above mentioned directive and are not allowed for use

within the European community and countries that have adopted the European

R&TTE directive 1999/5/EC.

For more details on legal combinations of power levels and antennas, contact Alcon

Compliance.

Equipment contains radio transmitters:

Wireless LAN device (WiFi)

Frequency or frequency band of transmission: 2.412 – 2.462 GHz

Type and frequency characteristics of the modulation: CCK, DQPSK, DBPSK,

OFDM

The Effective Radiated Power (ERP): 17 – 18dBm (50 – 64mW)

Radio Frequency Identification (RFID) device

Frequency or frequency band of transmission: 13.56 MHz

Type and frequency characteristics of the modulation: ASK

The Effective Radiated Power (ERP): -119 dBm (1260 pW)

Australia and New Zealand

This device complies with the Australian/New Zealand Standard AS/NZS 4268:

2003 Radio Equipment and Systems – Short Range Devices – Limits and methods

measurement, and AS/NZS 4771 (2000 + A1: 2003) Technical characteristics and test

conditions for data transmission equipment operating in the 900 MHz, 2.4 GHz and

5.8 GHz bands and using spread spectrum modulation techniques.

•

•

•

•

•

•

1.14 8065751025

Constellation® Vision System

Cautions and Warnings

Please contact Alcon for instrument setup and in-service training.

If you have any questions or require additional information, please contact your local

Alcon representative or the Technical Services Department. For locations outside the

USA, please contact your local authorized Alcon Service/Sales office.

• Good clinical practice dictates the testing for adequate irrigation, aspiration flow,

and operation as applicable for each handpiece prior to entering the eye.

• Do not use the Constellation® Vision System

system

near flammable anesthetics.

• Use only Alcon-supplied A.C. power cords. Prior to plugging the power cord into

its power source, ensure that the proper voltage selection has been made. See Care

and Maintenance section of this manual for instructions.

• Provide at least two feet of clearance at the rear of the unit for fan intakes and

exhausts. This ensures unrestricted air flow for adequate console cooling.

• A handle on the instrument cart is used for moving the instrument. The cart should

be pulled, not pushed, over elevator and door thresholds.

WARNING!

The Constellation® Vision System power cord is a medical grade power cord with

the least leakage current per foot rating available. Extension of the power cord

by hospital staff is not recommended. Unauthorized extension of the power cord

could result in injury.

Presurgical Setup Instructions

Presurgical setup instructions must be performed as outlined in this manual. If an

error message is displayed on the front panel, refer to Troubleshooting of this Manual.

If a problem persists, DO NOT PROCEED. Contact your local Alcon Surgical

Service Representative.

NOTE: If an inconsistency exists between the setup instructions in this manual and

the Directions For Use (DFU) supplied with a consumable pak, follow the DFU.

Vitreous Probes

Do not operate vitreous probes in air. This could result in performance degradation

and/or potential hazard.

8065751025 1.15

Constellation® Vision System

Cautions and Warnings

Ultrasonic Handpieces

Power loss may occur if handpiece tip is not securely tightened into Fragmentation

and Phaco handpieces.

WARNING!

Use of a Phaco handpiece at power settings greater than 80% continuously for

over 4 minutes can result in ultrasonic system failure. Allow the system to cool

for 8 minutes between heavy usage of this type.

If proper cleaning procedures are not performed immediately after each surgical

procedure, tissue debris and salts from irrigating solution may collect. This could

permanently damage the handpiece and could jeopardize cleanliness and/or create

biohazard conditions for the patient. Remove all debris prior to autoclaving handpiece.

CAUTION

Never ultrasonically clean the Fragmentation and Phaco handpieces; irreparable

damage will result.

WARNINGS!

Use of the phaco handpiece in the absence of irrigation flow and/or in the presence

of reduced or lost aspiration flow can cause excessive heating and potential

corneal and/or scleral burns.

Use of the Fragmentation handpiece in the absence of aspiration flow can cause

excessive heating and potential scleral burns.

Handpiece Tips

Scissors, frag, and phaco handpiece tips must be fully tightened to their handpieces. If

not secured properly, the handpieces may not operate correctly. Ensure, however, that

tips are not so tight that they cannot be removed after use. Use only Alcon supplied

fragmentation tip wrenches; otherwise, damage to tips and/or handpiece may occur.

WARNING!

For phaco surgery use only Alcon-certified Turbosonics® MicroTip™ configurations

(.9 mm). Alcon does not recommend the use of standard Turbosonics® tips (1.0

mm) with the Constellation® Vision System.

1.16 8065751025

Constellation® Vision System

Diathermy Function

To ensure safe operation of the Diathermy function, use only Alcon cables and

accessories. Diathermy performance can be guaranteed only when using Alcon

Surgical components or Alcon-endorsed components. Cables should always be

positioned in such a way that contact with the patient is prevented.

See Figures 1-4 through 1-6 for diathermy power specifications.

WARNING!

• Do not use the diathermy function on patients with pacemakers or implanted

defibrillatory devices. If electrosurgery is used on patients with implanted

cardiac pacemakers or defibrillatory devices or pacemaker electrodes, be aware

that irreparable damage to the pacemaker or defibrillatory device and its function

may occur and lead to ventricular fibrillation. Please check with the pacemaker

or defibrillatory device manufacturers for their recommendations.

• Failure of the HF surgical equipment (diathermy circuitry) could result in an

unintended increase of output power.

Listed below are general precautions to be followed when using the Diathermy function:

• To ensure safe operation of the

Diathermy

function, only approved cables and

accessories must be used (See your Alcon representative).

Diathermy

performance

can be guaranteed only when using Alcon components or Alcon-endorsed

components.

• To reduce the risk of accidental burns, caution should always be taken when

operating high-frequency surgical equipment.

• Interference produced by the operation of high-frequency surgical equipment may

adversely influence the operation of other electronic equipment.

• Accessories should be checked regularly; electrode cables should particularly be

checked for possible damage to the insulation.

• The lowest power level in

Diathermy

step should always be selected for the

intended purpose.

• Skin-to-skin contact (for example between the arms and body of the patient)

should be avoided, for example by insertion of dry gauze.

• When HF (high frequency) surgical equipment and physiological monitoring

equipment are used simultaneously on the same patient, any monitoring

electrodes should be placed as far as possible from the surgical electrodes. Needle

monitoring electrodes are not recommended.

• In all cases, monitoring systems incorporating high frequency current-limiting

devices are recommended.

• The cables to the surgical electrodes should be positioned in such a way that

contact with the patient or other leads is avoided.

• Temporarily unused active electrodes should be stored so that they are isolated

from the patient.

8065751025 1.17

Constellation® Vision System

• The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N2O)

and oxygen should be avoided if a surgical procedure is carried out in the region

of the thorax or the head, unless these agents are sucked away.

•

Non-flammable agents should be used for cleaning and disinfection wherever possible.

• Flammable agents used for cleaning or disinfecting, or as solvents of adhesives,

should be allowed to evaporate before the application of HF surgery. Some

materials, for example cotton, wool and gauze, when saturated with oxygen may

be ignited by sparks produced in normal use of the HF surgical equipment.

Illuminator Function

Housed inside Constellation® tabletop, the illuminator provides two channels of

illumination from a single xenon arc lamp. Two front panel sockets accept ACMI

compatible fiber optic light guides to provide intraocular illumination.

When installed, an optional illuminator is housed inside Constellation® base and

provides two channels of illumination from a single xenon arc lamp.

To gain access for bulb replacement or servicing, follow directions in section four of

this manual. Be aware that using the illuminator at high settings will reduce the life of

the bulbs.

WARNING!

The illuminator bulbs become extremely hot. Never handle a bulb until it has

cooled considerably from its operating temperature. Do not touch bulb directly

with fingers at any time.

The bulb of the xenon lamp is under constant high pressure. There is a risk it may

burst with explosive force if knocked or damaged. Protective measures:

— Keep the lamp in its protective sleeve at all times during installation

— If you are handling the lamp without its protective sleeve, always wear safety

goggles, a face mask, gauntlets with wrist protectors and a breast protector.

1.18 8065751025

Constellation® Vision System

Cautions and Warnings

Footswitch

Never pick up or move the footswitch by holding the cable. Damage may result.

Cassette

During initialization the drain pump is rotated to the home position; therefore, keep

hands and fingers clear of cassette well during power-on initialization. Manually

rotating the hub roller in the cassette well when power is on and a cassette is not

installed can cause incorrect cassette loading and/or can cause injury to fingers.

WARNINGS!

All fluids aspirated during surgery should be treated as biohazards. Take

appropriate precautions when handling instruments and lines in contact with

aspirated fluids.

Drain bag volume should not exceed 500cc “Max. Capacity.” Exceeding this

volume may result in a biohazardous condition.

Consumables

Do not use consumable paks beyond the expiration date stamped on the outer

packaging. Sterile consumable medical devices should not be reused (Accreditation

Manual for Hospitals, 1982); they are intended for single use only. Improper usage

or assembly could result in a potential hazardous condition for the patient. Alcon

assumes no responsibility for complications that may arise as a result of the reuse or

improper usage of consumables.

The equipment used in conjunction with Alcon Constellation® Vision System

consumables constitutes a complete system. Use of consumables other than Alcon

consumables may affect system performance and create potential hazards, and if it

is determined to have contributed to the malfunction of the equipment under service

contract, could result in the voidance of the contract and/or invoicing at prevailing

hourly rates.

WARNING!

Attach only Alcon supplied consumables to console and cassette luer fittings. Do

not connect consumables to the patient’s intravenous connections.

In all cases, the instrument setup instructions contained in this manual, and all label

instructions in the package, should be thoroughly understood prior to using any of the

Constellation® Vision System Pak configurations.

Ensure that tubing is not occluded during any phase of operation.

8065751025 1.19

Constellation® Vision System

Cautions and Warnings

Consumable Paks

If any item in a consumable pak is received in a defective condition, Alcon is to be

notified immediately. Do not use any of the contents if the sterile package is damaged

or the seal is broken in any way. Paks are identified by lot number that provides

traceability and should be given to the Customer Service Department.

Phone Alcon Customer Service At: Please Write To Alcon At:

(800) 862-5266 or Alcon

(817) 293-0450 Attn: Product Complaints

6201 South Freeway

Fort Worth, TX 76134-2099

Diathermy, Cautery, Coagulation

In the past, some of Alcon’s products have referred to the feature “Cautery” or

«Coagulation.» The Constellation® Vision System and this operator’s manual use the

word “Diathermy” based on the following definitions:

• Diathermy — introducing an electric field into a body part to produce heat.

• Cautery — cutting and burning method associated with two hot wires passing a

current between them; cutting away skin; halting bleeding.

• Coagulation — an isolated bipolar current supplied to conductors (e.g. forceps).

Current passes between these electrodes, halting bleeding.

1.20 8065751025

Constellation® Vision System

Figure 1-4 DIATHERMY POWER THROUGH 75 OHM LOAD

Figure 1-5 DIATHERMY POWER VS. LOAD IMPEDANCE

Figure 1-6 DIATHERMY OUTPUT VOLTAGE VS. OUTPUT CONTROL SETTING

Note: Maximum output peak-to-peak voltage is about 140V without resistive load.

8065751025 1.21

Constellation® Vision System

PRODUCT SERVICE

For product service, please contact Alcon’s Technical Services Department at the

number provided below.

Operators experiencing problems with the system should refer to the Operating

Instructions and Troubleshooting sections of this manual. A problem which persists

should be referred to the Alcon Technical Services Department or your local

authorized service representative.

For optimum performance, it is the user’s responsibility to schedule preventive

maintenance service on the system and its accessories one time each year. Alcon’s

Field Service Engineers are trained and equipped to provide the highest quality of

workmanship.

Safety performance should be verified by the user (e.g., qualified service personnel)

at least twice a year. Ground resistance must be under 0.1 ohms. Leakage current

must be under 500 µA.

To avoid unnecessary shipping, please contact your Alcon Technical Services

Department prior to the return of any system or accessories. If return of the equipment

is deemed necessary, a Return Material Authorization will be issued with appropriate

shipping instructions.

Alcon Laboratories, Inc.

Technical Services Department

15800 Alton Parkway

Irvine, California 92618-3818

(949) 753-1393

(800) 832-7827

1.22 8065751025

Constellation® Vision System

LIMITED WARRANTY

Alcon Laboratories, Inc., will repair or replace at its option, any system or

accompanying accessories (excluding the optical fiber) found to be defective in

material and/or workmanship for a period of one (1) year from the date of initial

installation. This warranty applies to the original purchaser of the system, when said

system is properly installed, maintained, and operated in accordance with published

instructions.

Alcon Laboratories shall not be obligated to provide services under this warranty for

damage to or destruction of systems covered where such damage or destruction is (i)

a result of or caused by fire or explosion of any origin, riot, civil commotion, aircraft,

war, or any Act of God including, but not limited to lightning, windstorm, hail,

flood, earthquake, or (ii) caused by customer’s misuse or improper servicing of said

systems.

The express warranty above is the sole warranty obligation of Alcon, and the

remedy provided above is in lieu of any and all other remedies. There are no other

agreements, guarantees, or warranties — oral or written, express or implied — including

without limitation warranty of merchantability or fitness for a particular purpose.

Alcon shall have no liability whatsoever for any incidental or consequential damages

arising out of any defect, improper use, or unauthorized service or repair.

WARNING!

The disposables used in conjunction with Alcon instrument products constitute

a complete surgical system. Use of disposables and handpieces other than those

manufactured by Alcon may affect system performance and create potential

hazards. If it is determined that disposables or handpieces not manufactured

by Alcon have contributed to the malfunction of the equipment during warranty

period, service will be provided at prevailing hourly rates.

LAST PAGE OF THIS SECTION

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OPERATOR’S MANUAL

Manufacturer: EU Authorized Representative:

Alcon Laboratories, Inc. Alcon Laboratories (U.K.) Ltd.

6201 South Freeway Boundary Way, Hemel Hempstead

Fort Worth, Texas 76134-2099 Hertfordshire, HP2 7UD England

U.S.A.

Produced By:

Alcon Laboratories, Inc.

15800 Alton Parkway

Irvine, California 92618-3818

U.S.A.

Telephone: 949/753-1393

800/832-7827

FAX: 949/753-6614

8065751025 Rev. P3, CATALOG NUMBER

905-2120-001 Rev. P3.1, TEXT ONLY © 2007 Alcon, Inc.

ii 8065751025

Constellation® Vision System

Constellation® Operator’s

8065751025

MANUAL REVISION RECORD

DATE REVISION ECN NUMBER AND DESCRIPTION

* Registered U.S. Patent & Trademark Office

9/15/06 P1

7/2/07 P2 (no PECN)

9/1807 P3

8065751025 iii

Constellation® Vision System

TABLE OF CONTENTS

TOPIC PAGE #

Manual Revision Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

Important Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

SECTION ONE — GENERAL INFORMATION

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

System Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7

Source Air Pressure Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7

Accessory Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7

Settings Restoration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7

Environmental Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8

User Information — Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8

Universal Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9

EMC Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9

FCC and IC Compliance Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12

EU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12

Australia and New Zealand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12

Cautions and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.13

Diathermy, Cautery, Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.18

Product Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.20

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.21

SECTION TWO — DESCRIPTION

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1

Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2

Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5

Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7

Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.8

Front Panel Displays And Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.12

Global Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.37

System State Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.41

Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.58

Surgical Modes And Submodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.65

End Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.94

Probes and Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.98

The Constellation Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.106

Consumable Pak Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.107

Combined Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.107

Posterior Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.108

Anterior Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.108

SECTION THREE — OPERATING INSTRUCTIONS

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Power Up Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1

Initial System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2

Constellation™ Procedure Pak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3

Procedure Pak and Cassette Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4

Posterior Segment Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5

Anterior Segment Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.6

Auto Gas Filler Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.8

Fragmentation Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.9

Viscous Fluid Control Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.10

Extrusion Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12

iv 8065751025

Constellation® Vision System

Fiber Optic Illuminator Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12

Diathermy Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12

Pneumatic Handpiece Setup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.13

SECTION FOUR — CARE AND MAINTENANCE

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1

Upon Completion Of The Day’s Surgery Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2

Sterilization Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3

Reusable Handpiece and Accessories Cleaning and Sterilization Instruction . . . . . . . . . . . . . . . . . . . . . . . 4.4

Disposal of Xenon Lamps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8

SECTION FIVE — TROUBLESHOOTING

Equipment Malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1

System Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2

Advisory Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3

Information Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3

SECTION SIX — ACCESSORIES AND PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1

SECTION SEVEN — INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

TABLE OF CONTENTS

TOPIC PAGE #

8065751025 v

Constellation® Vision System

FIGURE # TITLE PAGE #

LIST OF ILLUSTRATIONS

Figure 1-1 The Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1

Figure 1-2 Icons used with the Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.5

Figure 1-3 Labeling used on the Constellation® Vision System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.6

Figure 1-4 Diathermy Power Through 75 Ohm Load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19

Figure 1-5 Diathermy Power Vs. Load Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19

Figure 1-6 Diathermy Output Voltage Vs. Output Control Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.19

Figure 2-1 The Constellation® Vision System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.2

Figure 2-2 The Constellation® Vision System Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.5

Figure 2-3 The Constellation® Vision System Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.7

Figure 2-4 The Constellation® Vision System Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.8

Figure 2-5 Remote Control Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.10

Figure 2-6 Remote Control Channel Selection Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.11

Figure 2-7 The Startup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.12

Figure 2-8 The Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.13

Figure 2-9 The Main Screen Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.14

Figure 2-9a Procedure Modify Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.16

Figure 2-10 The Doctor Settings Popup — General Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.19

Figure 2-10a The Doctor Settings Popup — Surgery/Inf/Irr Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.20

Figure 2-10b The Doctor Settings Popup — Surgery/Reflux Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.21

Figure 2-10c The Doctor Settings Popup — Surgery/General Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.22

Figure 2-11 Doctor Settings — Footswitch Buttons Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.23

Figure 2-12 Footswitch Action Selection Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.24

Figure 2-13 Doctor Settings — Footswitch Treadle Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.25

Figure 2-14 Doctor Settings — Sound Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.26

Figure 2-15 Doctor Settings — Laser Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.27

Figure 2-16 Deleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.27

Figure 2-17 System Settings — Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.28

Figure 2-18 System Settings — Connections Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.29

Figure 2-19 System Settings — VideoOverlay Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.30

Figure 2-20 Auto Gas Fill Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.31

Figure 2-21 View/Copy/Delete Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.32

Figure 2-22 Sample View of a Doctor Settings Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.34

Figure 2-23 Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.35

Figure 2-24 About Constelllation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.35

Figure 2-25 Infusion Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.37

Figure 2-26 F/AX Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.38

Figure 2-27 Irrigation Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.39

Figure 2-28 Diathermy Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.39

Figure 2-29 Illuminator Global Control and Advanced Setup Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.40

Figure 2-30 The Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.41

Figure 2-31 The Fluidics Popup Screen(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.42

Figure 2-32 The Probe Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.43

Figure 2-33 The Handpiece Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.44

Figure 2-34 The Accessory Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.45

Figure 2-35 The Illuminator Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.46

Figure 2-36 The Laser Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.47

Figure 2-37 The Fluidics Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.49

Figure 2-38 The Detailed Probe Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.50

Figure 2-39 The Detailed Handpiece Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.51

Figure 2-40 The Detailed Accessory Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.52

Figure 2-41 The Detailed Illuminator Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.53

vi 8065751025

Constellation® Vision System

Figure 2-41a The Detailed Laser Setup Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.54

Figure 2-42 Video Help Popups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.55

Figure 2-43 Prime & Test Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.56

Figure 2-44 Consumables Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.56

Figure 2-45 Timer Configuration Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.57

Figure 2-46 The Surgery Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.58

Figure 2-47 Vacuum Control and Settings Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.59

Figure 2-48 Surgical Control Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.60

Figure 2-49 Surgical Control with Dropdown List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.61

Figure 2-50 Accurus® Classic Surgery Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.63

Figure 2-51 Surgical Step Panel — Custom Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.63

Figure 2-51a Surgical Step Panel Scroll Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.64

Figure 2-52 Surgery Screen: Vitrectomy Mode-3D Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.66

Figure 2-53 Surgery Screen: Vitrectomy Mode-Momentary Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.68

Figure 2-54 Surgery Screen: Vitrectomy Mode-PropVac Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.69

Figure 2-55 Surgery Screen: Vitrectomy Mode-VitWet Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.70

Figure 2-56 Surgery Screen: Phaco Mode — Burst Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.72

Figure 2-57 Surgery Screen: Phaco Mode — Custom Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.74

Figure 2-58 Surgery Screen: Phaco Mode — Pulsed Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.76

Figure 2-59 Surgery Screen: Phaco Mode — Continuous Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.78

Figure 2-60 Surgery Screen: Fragmentation Mode — Fixed Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.79

Figure 2-61 Surgery Screen: Fragmentation Mode — Linear Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.81

Figure 2-62 Surgery Screen: Fragmentation Mode — Momentary Submode . . . . . . . . . . . . . . . . . . . . . . . .2.82

Figure 2-63 Surgery Screen: Irrigation/Aspiration Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.83

Figure 2-64 Surgery Screen: Extrusion Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.85

Figure 2-65 Surgery Screen: Laser Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.87

Figure 2-66 Surgery Screen: Forceps Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.89

Figure 2-67 Surgery Screen: Scissors Mode — MultiCut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.90

Figure 2-68 Surgery Screen: Scissors Mode — Proportional . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.91

Figure 2-69 Surgery Screen: VFC Mode — Extract Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.92

Figure 2-70 Surgery Screen: VFC Mode — Injection Submode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.93

Figure 2-71 End Case Screen: Anterior Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.94

Figure 2-72 End Case: Setup Form Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.95

Figure 2-73 UltraVit Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.98

Figure 2-74 Pneumatic Scissors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.98

Figure 2-75 Fragmentation Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.99

Figure 2-76 Infiniti™* Ultrasonic (U/S) Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.99

Figure 2-77 TurboSonics® Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.101

Figure 2-78 Infiniti™* U/S Handpiece shown with Infusion Sleeve and Bubble Suppression Insert . . .2.102

Figure 2-79 Ultraflow™* IT handpiece and tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.104

Figure 2-80 Ultraflow™* IT handpiece with infusion sleeve, reusable I/A tip, and threaded tip adapter 2.104

Figure 2-81 Ultraflow™* O-ring tool with large and small O-rings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.104

Figure 2-82 Ultraflow™* SP handpiece (handpiece shown with .3 mm 45° tip) . . . . . . . . . . . . . . . . . . .2.104

Figure 2-83 Single use bipolar brush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.105

Figure 2-84 The Constellation® Combined Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.106

Figure 4-1. Auto Wash: Handpiece with «Y» Adapter Connected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6

Figure 4-2. Auto Wash: «Y» Adapter Connected to Injector Nozzel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6

Figure 4-3. Auto Wash: Unused Injectors Shown Plugged Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6

Figure 4-4. Depressurizing the Xenon Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.8

Figure 5-1 System Fault Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.1

Figure 5-2 System Error Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.2

Figure 5-3 Advisory Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.3

Figure 5-4 System Information Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.3

8065751025 vii

Constellation® Vision System

LIST OF TABLES

Table 1-1 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.2

Table 1-2 Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.4

Table 1-3 Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.10

Table 1-4 Recommended Separation Distances Between Portable and Mobile RF

Communications Equipment and the Constellation® Vision System . . . . . . . . . . . . . . . . . . .1.11

Table 2-1. Surgical Modes And Submodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.66

Table 6-1. Constellation® Vision System Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.1

TABLE # TITLE PAGE #

viii 8065751025

Constellation® Vision System

FOREWORD

This Operator’s Manual is designed to acquaint the operator and operating room personnel with

the Constellation® Vision System. The manual presents an organized summary of the operating

principles, main components, safety features, and instructions for care and use of the instrument.

The information in this manual should be supplemented with reference works on laser theory and the

interaction of laser energy with biologic tissues. No attempt is made in this manual to answer all the

questions that arise during the use of the instrument in medical procedures.

Questions concerning technique, safety and effectiveness should be referred to pertinent publications

or recognized medical experts in laser surgery. Physicians should not attempt to treat patients with

this instrument if not thoroughly familiar with its operation, or if in doubt as to its safe operation. All

personnel authorized to use this instrument should be required to be thoroughly familiar with this

manual.

Please contact Alcon for complete technical support and service if you have questions concerning any

aspect of this instrument’s operation or if it fails to perform satisfactorily.

To order supplies in U.S.A.:

800-862-5266

FAX: 800-241-0677

Outside U.S.A.: Contact your local Alcon representative for supplies.

8065751025 ix

Constellation® Vision System

IMPORTANT NOTICE

Equipment improvement is an on-going process and, as such, changes may be made to the equipment

after this manual is printed.

Pay close attention to WARNINGS and CAUTIONS in this manual. WARNINGS are written to

protect individuals from bodily harm. CAUTIONS are written to protect the instrument from damage.

Illustrations contained in this manual are for reference only.

It is recommended that maintenance be performed by a qualified Alcon Field Engineer.

Alcon Surgical shall not be liable for any damage resulting from failure to comply with the enclosed

instructions.

Alcon reserves the right to change specifications without further notice.

Operator Profile

The Constellation Vision System is designed to be operated by two basic groups; surgeons and

nurses/scrub techs. The surgeon focus is primarily constrained to the footswitch and display panel.

The design of the footswitch allows the surgeon to map any function to any switch position,

assuming the function is valid in a particular scenario. The display screen was designed to mount

on an articulating arm to allow optimum placement of the display so the surgeon can reference it at

any time. The design also incorporated items specifically for nurses and scrub techs, who routinely

control the machine via the front panel and remote control. The design incorporates color coding on

all connectors and tubing to facilitate easy identification of the ports. In addition, the graphical user

interface closely resembles controls commonly found on web sites, which this operator profile is

expected to be highly proficient at using.

CAUTION

U.S. Federal Law restricts this device to sale by or on the order of a physician only.

WARNINGS!

For systems containing the optional laser module: Use of controls or adjustments, or

performance of procedures other than those specified herein may result in hazardous

laser radiation exposure.

A qualified technician must perform a visual inspection of the following components

every twelve months. In case of a deficiency, do not use the system; call Alcon Technical

Services.

— Warning Labels

— Power Cord

— Fuses

A qualified technician must check ground continuity and both polarities for leakage

current every twelve months to ensure they are within the applicable standard (for

example: EN 60601-1/IEC 601-1). Values must be recorded, and if they are above the

applicable standard, or 50% above your first measurement, do not use the system; call

Alcon Technical Services.

Use of accessories and cables other than those provided may result in increased

emissions or decreased immunity of the system. Portable and mobile RF

communications equipment can affect this medical electrical equipment.

x 8065751025

Constellation® Vision System

LAST PAGE OF THIS SECTION

Comments or corrections concerning this manual should be addressed to:

Alcon

Technical Services Group

PO BOX 19587

Irvine, CA, USA 92623

All rights reserved. No part of this manual may be reproduced, transmitted, or stored in a retrieval

system, in any form or by any means; photocopying, electronic, mechanical, recording, or otherwise;

without prior written permission from Alcon Laboratories, Inc.

8065751025 1.1

Constellation® Vision System

SECTION ONE

GENERAL INFORMATION

Introduction

The Constellation® Vision System is a multifunctional surgical tool for use in anterior

and posterior segment ophthalmic surgeries. The product’s capabilities include

driving a variety of handpieces that provide the ability to cut vitreous and tissues,

emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to

stop bleeding. Vacuum is used to remove ocular matter from the eye and is provided

by connecting tubing from the handpiece to a port on the fluidics cassette. Irrigation/

infusion capability is provided to replace fluid in the eye, and enters the eye directly

via either an infusion cannula or flows through a handpiece. The graphical operator

interface is menu driven. The operator provides inputs using the touchscreen panel,

the remote control, voice commands, and the footswitch.

Figure 1-1 The Constellation® Vision System — The Constellation® Vision System is

a multifunctional surgical tool is used in anterior and posterior segment

ophthalmic surgeries.

1.2 8065751025

Constellation® Vision System

CONSOLE

DIMENSIONS:

Tabletop:

Height: 160.0 cm (63.0 inches)

Width: 76.2 cm (30.0 inches)

Depth: 77.5 cm (30.5 inches)

Base:

Height: 63.5 cm (25.0 inches)

Width: 53.3 cm (21.0 inches)

Depth: 57.2 cm (22.5 inches)

WEIGHT:

Tabletop: 61.2 kg (135 pounds)

Base: 72.6 kg (160 pounds)

ENVIRONMENTAL LIMITATIONS:

Operating Non-Operating

Altitude: -125 to 2000 m -125 to 3000 m

(-410 to 6562 feet) (-410 to 9843 feet)

Temperature: 10° C to 35° C -10 to 55°C

(50° F to 95° F) (14° F to 131° F)

Relative Humidity: 10% to 95% 10% to 95%

without without

condensation condensation

ELECTRICAL REQUIREMENTS: The console accepts the following

ranges or input commercial power voltages and frequencies and meets

the leakage currents specified in IEC 60601-1. Protection against electrical

shock is Class I.

100-120 Vac 50/60 Hz 12 A max. Fuse: T 10 A / 250 V slow blow

220-240 Vac 50/60 Hz 7.5 A max. Fuse: T 5 A / 250 V slow blow

FOOTSWITCH

DIMENSIONS:

Height: 14.0 cm (5.50 inches)

Width: 22.9 cm (9.00 inches)

Depth: 43.2 cm (17.0 inches)

WEIGHT: 5.4 kg (12 pounds)

ENVIRONMENTAL: The footswitch construction is water tight in

compliance with IEC 60601-1 and IEC 60601-2-2, subclause 44.6 aa.

ELECTRICAL: The footswitch is connected to the console via electrical

cable.

All power and communications enter/exit the footswitch from this

cable.

Table 1-1 CONSTELLATION® VISION SYSTEM SPECIFICATIONS — This table is a quick reference point to

identify system specifications, system requirements, and performance figures.

PERFORMANCE SPECIFICATIONS

PRESSURIZED INFUSION/IRRIGATION @SEA LEVEL:

Range: 0 to 120 mmHg

Accuracy: ±(2% of setpoint +5 mmHg)

Flow Rate: 0 — 20 cc/min. for infusion (20 Ga)

0 — 60 cc/min. for irrigation

Setpoint Transient: 500 ms maximum

IOP CONTROLLED INFUSION:

Setpoint Range: 0-120 mmHg

Repeatability1: ± 2 mmHg2

Setpoint Response Time: <500 ms (20 Ga)

Transient Disturbance

Response Time: <500 ms3

Flow Range: 0-20 cc/min

1 BSS Dual chamber mode.

2 BSS medium, 20 gauge high flow Cannula, steady state condition

at rated flow range

3 Transient condition from no flow state to 10cc/min

ASPIRATION/SUCTION @SEA LEVEL:

Standard & Reduced

Pressure Range: 0-650 mmHg Vacuum

Minimal Pressure Range: 0-600 mmHg Vacuum

Pressure Accuracy: ±(2% of Setpoint +5 mmHg)

Flow Range:

Posterior Modalities: 0-20 cc/min

Anterior Modalities: 0-60 cc/min

Transient Response Time

(Standard Pressure Range): From– 0 to -400 mmHg @0 cc/min

10-90% Rise Time:300 msec max

90-10% Fall Time: 300 msec max

IRRIGATION/ASPIRATION @SEA LEVEL:

Sub Modes: Cap Vac, I/A Max

Vacuum:

Standard & Reduced

Pressure Range: 0 to -650 mmHg

Minimal Pressure Range: 0 to -600 mmHg Vacuum

Vacuum Accuracy: 2% of displayed value + 5

mmHg

Flow Rate: 10 cc/min minimum + 1.5cc at

50 mmHg vacuum max

VACUUM @ SEA LEVEL:

Vitrectomy: 0 to 650 mmHg

Fragmentation: 0 to 650 mmHg

Extrusion: 0 to 650 mmHg

Extraction: 0 to 650 mmHg

Irrigation/Aspiration: 0 to 650 mmHg

Phacoemulsification: 0 to 650 mmHg

8065751025 1.3

Constellation® Vision System

PERFORMANCE SPECIFICATIONS…continued

LOW PRESSURE AIR SOURCE (LPAS) @SEA LEVEL:

Pressure Range: 0 – 120 mmHg at rated flow

Pressure Accuracy: ±3% of Setpoint +3 mmHg

Flow Rate: 1.2 slpm minimum at 120 mmHg

VITRECTOMY:

Submodes: 3D, Momentary, PropVac, VitWet

Cut Rate:

UltraVit™ 5000 Probe: 100 to 5000 cpm

UltraVit™ 2500 Probe: 100 to 2500 cpm

DIATHERMY:

Frequency: 1.5 Mhz ± 10%.

Waveshape: Sinusoidal

Output power 10 Watts maximum at 100% setting

with 75 ± 10% ohm non-inductive load

Power range 0 — 100% of maximum output power

ILLUMINATION:

Lumen Accuracy: ±30%

Light Output through 20GA 0.5

NA Fiber Probe: 0-200 hrs: 50 lumens minimum

at 100% setting

201-400 hrs:25 lumens minimum

at 100% setting

Light Output through

25GA 0.63 NA Fiber Probe: 0-200 hrs: 15 lumens minimum

at 100% setting

201-400 hrs:10 lumens minimum

at 100% setting

FRAGMENTATION:

Submodes: Linear, Fixed, Momentary

Tip Stroke @ 100%: 3.1 ± 0.5 mils at 100% power

Resonant Frequency: 39.0 ± 1.9 KHz

Pulse Rate Range: 0 – 100 pps

SCISSORS:

Submodes: Proportional, Multi-Cut

Proportional Pressure: 0-50 psi @sea level

Multi Cut Rate: single cut to 450 cpm

PROPORTIONAL AND CONTINUOUS REFLUX @SEA LEVEL:

Pressure Range: 0 to 120 mmHg

Pressure Accuracy: ±(2% of Setpoint +5 mmHg)

MICRO REFLUX:

Pressure Range: 100 ± 15% mmHg1

Volume: 50 ± 10 µL1

1 measured with unoccluded Accurus® probe and aspiration tubing

VISCOUS FLUID CONTROL:

Submodes: Inject, Dual, Extract

Injection Pressure: 0 to 551.6 KPascal (0 to 80 psi)

0 to 482.7 KPascal

@ Reduced (0 to 70 psi)

Extract Vacuum

at Sea Level:

0 to 650 mmHg

Table 1-1 CONSTELLATION® VISION SYSTEM SPECIFICATIONS…continued

AUTO-GAS FILLING (AGF):

Maximum Gas Pressure: 10 psig

Fill Purity: 99.9% gas concentration

following fill

AUTO-STOPCOCK:

Response Time: 0.5 seconds minimum

Pressure (Liquid): 0-120 mmHg

Rated Flow (Liquid): 20 cc/min

Pressure (LPAS): 0-120 mmHg

Rated Flow (LPAS): 1.2 slpm

PHACOEMULSIFICATION:

Submodes: Burst, Pulsed, Continuous

Tip Stroke @ 100%: 3.5 ± 0.5 mils

Resonant Frequency: 34khz – 42Khz ± 10%.

Pulse Rate Range: 0-100 pulses per second

Burst Length: 2.5 sec – user adjustable

Burst Pulse durations: 5ms to 500ms

ANTERIOR VITRECTOMY:

Submodes: Wet, Dry

Cut Rate: 0 to probe maximum

LASER (optional):

Treatment beam:

Class: IV

Power: 30 mW to 2 W (maximum)

Wavelength: 532 nm

Aiming beam:

Class: II

Power: less than 1mW

Wavelength: 635 nm ± 5 nm

DOCTOR MEMORIES:

Storage Capacity: xxx Doctors

Memory Cells per Dr: xx (xx anterior, xx posterior, xx common)

TIMER:

Range: 0 to xx h

Resolution: 1 s

TONE VOLUMES @ 1 Meter:

Errors/Faults/Invalid Key: 40 to 65 dB, short tones

Diathermy: 40 to 65 dB, continuous tone

Advisory/Timer Expire/Elev Infusion: 0 to 65 dB, short tones

Frag/Phaco/Vacuum: 0 to 65 dB, continuous tone

Valid Key: Factory set and not adjustable

Volume Accuracy: 6 dB

VOICE CONFIRMATION: 0 to 65 dB

REMOTE CONTROL:

Method: Infrared

Channels: 4

1.4 8065751025

Constellation® Vision System

Term or Abbreviation

BSS PLUS®

cmH2O

cpm

Detent

Diathermy

Extrusion

F/AX

Frag

Global Function

Highlighted

I/A

IEC

ISO

IV

LCD

mmHg

N/A

PEL

PIN

psi

pps

slpm

U/S

VFC

Vit

Description

Balanced Salt Solution enriched with bicarbonate, dextrose, and glutathione.

Centimeters of water.

Cuts Per Minute.

A discrete footpedal position at which more force is required to depress the footpedal to

the next position.

The production of heat in body tissues by electric current for therapeutic purposes.

A mode where vacuum is available to remove fluid/matter.

Fluid Air Exchange.

Fragmentation.

A function whose status and controls are independent of the current footpedal position

and surgery mode.

To center attention by video reversing the function key and changing the key color from

gray to blue.

Irrigation/Aspiration.

International Electromechanical Commission.

International Standards Organization.

Intravenous.

Liquid Crystal Display.

Millimeter of Mercury. A unit of vacuum.

Not Applicable.

Patient Eye Level. A difference in height between the cassette and the patient eye level.

Personal Identification Number.

Pressure per Square Inch. A unit of pressure.

Pulses Per Second.

Standard Liters Per Minute.

Ultrasound.

Viscous Fluid Control.

Vitrectomy. Extraction of the vitreous from the vitreous cavity.

Table 1-2 Terms and Abbreviations

8065751025 1.5

Constellation® Vision System

Figure 1-2 ICONS USED WITH THE Constellation® Vision System — Icons identifying modes, functions, etc., that

are used with the Constellation® Vision System are identified in this chart.

Extrusion

Forceps

Fragmentation

Irrigation/

Aspiration

Laser

Phaco

Scissors

Viscous

Fluid

Control

(VFC)

Vitrectomy

Expand

Window

Help Video

Modify

Power

Save

Air Pressure

Input

Auto Gas Filling

(AGF)

Alternating

Current

Coagulation

Connector

Connection

Indicator

Dangerous

Voltage

Eject

Equipotentiality

Footswitch

Forceps

Fuse

Hot

Illuminator

Laser

Connection

Laser

Emergency Stop

Switch

Laser Port 1

Tethered Laser

Network

Connection

Off

On

Consult

Operator’s

Manual, or

System Error or

Advisory

Opens

Operator’s

Manual

Video Recorder

Scissors

Connector

Serial In/Out

Standby State

System Fault

System

Information

Type BF

Equipment

Type B

Equipment

U/S Handpiece

Connector

USB Connector

Use appropriate

take-back

system (see

Environmental

Considerations in

this manual).

Viscous

Fluid Control

Connector

VGA Out

Video In/Out

Vitreous Cutter

Connection

1.6 8065751025

Constellation® Vision System

Figure 1-3 LABELING USED ON THE CONSTELLATION® VISION SYSTEM — Labels used on the Constellation®

Vision System console are identified and illustrated here.

Labels for gas containers

8065751025 1.7

Constellation® Vision System

System Installation

In the USA contact the Alcon Technical Services Department for uncrating and

installation at (800) 832-7827. Outside the USA contact your local Alcon affiliate.

Source Air Pressure Requirements

The Constellation® Vision System

is designed to operate using different levels of

source air pressure. The system operates automatically with pressures of 58 (4 bar) to

120 psi (8.3 bar). Between 4 bar and 5 bar, vacuum performance is reduced. Between

4 bar and 5.5 bar, VFC inject performance is reduced.

Accessory equipment connected to or used with this equipment must be certified

according to the respective IEC Standard (e.g., IEC 60950 for data processing

equipment, and IEC 60601-1 for medical equipment). The Constellation® is shipped

with English and metric air fittings compliant with EN739:1998. Anyone connecting

additional equipment or otherwise causing a different system configuration than

provided by Alcon is responsible for continued compliance to the requirements

of System Standard IEC 60601-1-1. If in doubt, consult the Technical Services

department or your local Alcon representative.

Settings Restoration

When a loss of power occurs, the Constellation® Vision System retains its current

settings and mode in memory. When power is reestablished a System Information

popup window appears asking:

«Do you want to restore the system’s previous settings and mode?»

The user can press Yes to restore the previous settings, or No to enter the default

settings. Disconnecting the power cord, or turning the system off using the rear panel

power switch, is considered a loss of power; using the rear panel standby switch is

not.

1.8 8065751025

Constellation® Vision System

Environmental Issues

Follow local governing ordinances and recycling plans regarding disposal or

recycling of device components.

WARNINGS!

Laser: There are potential hazards when inserting, steeply bending, or improperly

securing the fiberoptic. Not following the recommendations of the manufacturer

may lead to damage of the fiber or delivery system and/or harm to the patient or

user.

Since the aiming beam passes down the same delivery system as the treatment

beam, it provides a good method of checking the integrity of the delivery system.

If the aiming beam spot is not present at the distal end of the delivery system,

or its intensity is reduced or it looks diffused, this a possible indication of a

damaged or not properly working delivery system. If there is any doubt, contact

Alcon Technical Services.

The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O)

and oxygen should be avoided. Some materials — for example cotton wool when

saturated with oxygen — may be ignited by the high temperatures produced in normal

use of the laser equipment. The solvents of adhesives and flammable solutions

used for cleaning and disinfecting should be allowed to evaporate before the laser

equipment is used. There is also danger of ignition of endogenous gases.

User Information — Environmental Considerations

The equipment that you have purchased requires the use of natural resources for its

production. This equipment may also contain hazardous substances which could have

potential effect on the environment and human health if disposed of improperly.

In order to avoid the entry of any such substances into our environment and to

promote natural resource conservation, we encourage you to use the appropriate take-

back systems. Such take-back systems reuse or recycle many of the materials in your

end-of-life equipment in a beneficial way. Please contact your local Alcon office for

assistance in take-back options through Alcon or other providers.

The crossed-bin symbol located on this equipment reminds you to use take-back

systems, while also emphasizing the requirement to collect waste equipment

separately, and not dispose of it as unsorted municipal waste.

If you need more information on the collection, reuse or recycle systems available to

you, please contact your local or regional waste administration, or contact your local

Alcon office for more information.

8065751025 1.9

Constellation® Vision System

Universal Precautions

Universal precautions shall be observed by all people who come in contact with the

instrument and/or accessories to help prevent their exposure to blood-borne pathogens

and/or other potentially infectious materials. In any circumstance, wherein the exact

status of blood or body fluids/tissues encountered are unknown, it shall be uniformly

considered potentially infectious and handled in accordance with OSHA guidelines.

EMC Statement

It is important to install and use the equipment in accordance with the instructions

in order to prevent harmful interference with other devices in the vicinity. If this

equipment causes harmful interference to other devices (determined by turning the

equipment off and on), the user is encouraged to try to correct the interference by one

or more of the following measures:

Reorient or relocate the other device(s).

• Increase the distance between the equipment.

• Connect this equipment into an outlet on a circuit different from that to which the

other device(s) is connected.

• Consult the manufacturer or your Alcon field service engineer for help.

Table 1-2 Guidance and Manufacturer’s Declaration — Electromagnetic Emissions — The Constellation®

Vision System is intended for use in the electromagnetic environment specified below. The

customer or the user of the system should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment-Guidance

RF emissions

CISPR 11

Group 1 The Constellation® Vision System uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause any interference

in nearby electronic equipment.

RF emissions

CISPR 11

Class A Based on extensive field experience the Constellation® Vision System is suitable

for use in all establishments other than domestic and those directly connected

to the public low voltage power supply network that supplies buildings used for

domestic purposes.

The EMC Statement provides guidance on steps to take in case of electromagnetic

interference.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

Flicker emissions

IEC 61000-3-3

Complies

1.10 8065751025

Constellation® Vision System

Table 1-3 Guidance and Manufacturer’s Declaration — Electromagnetic Immunity — The Constellation®

Vision System is intended for use in the electromagnetic environment specified below. The

customer or the user of the Constellation® Vision System should assure that it is used in

such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment-Guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

• ±6 kV contact

• ±8 kV air • ±6 kV contact

• ±8 kV air

Floors should be wood, concrete, or ceramic tile. Do

not use around floors that are covered with synthetic

material to avoid laser stoppage due to ESD.

Electrical fast

transient/burst

IEC 61000-4-4

• ±2 kV for power

supply lines

• ±1 kV for input/output

lines

• ±2 kV for power

supply lines

• ±1 kV for input/

output lines

Mains power quality should be that of a typical

commercial or hospital environment. To avoid laser

stoppage due to fast transients avoid powering the

Constellation® Vision System on the same branch

circuit with sources that can generate fast transients

(inductive switching; e.g., high current motors).

Surge

IEC 61000-4-5 • ±1 kV differential

mode

• ±2 kV common mode

• ±1 kV differential

mode

• ±2 kV common

mode

Mains power quality should be that of a typical

commercial or hospital environment. To avoid

laser stoppage due to power-line surges consider

powering the Constellation® Vision System through

branch circuit that has surge suppressor for

protection against lightning surges (e.g., at power

panel to surgical/office suite).

Voltage dips, short

interruptions, and

voltage variations

on power supply

input lines

IEC 61000-4-11

• <5% UT (>95% dip in

UT) for 0.5 cycle

• 40% UT (60% dip in

UT) for 5 cycles

• 70% (30% dip in UT)

for 25 cycles

• <5% (>95% dip in

UT) for 5 sec

• <5% UT (>95% dip

in UT) for 0.5 cycle

• 40% UT (60% dip

in UT) for 5 cycles

• 70% (30% dip in

UT) for 25 cycles

• <5% (>95% dip in

UT) for 5 sec

Mains power quality should be that of a typical

commercial or hospital environment. If the uses of

the Constellation® Vision System require continued

operation during power mains interruptions, it is

recommended that the Constellation® Vision System

be powered from an uninterruptible power supply

or a battery.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at

levels characteristic of a typical location in a typical

commercial or hospital environment.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 Vrms

3V/m

Portable and mobile RF communications equipment

should be used no closer to any part of the

Constellation® Vision System, including cables, than

the recommended separation distance calculated

from the equation applicable to the frequency to

the transmitter.

Recommended separation distance:

d = 1.2√P

d = 1.2√P 80 MHz to 800 MHz

d = 2.3√P 800 MHz to 2.5 GHz

Constellation® Vision System

where P is the maximum output power rating to the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation

distance in meters (m).

Field strength from fixed RF transmitters, as

determined by an electromagnetic site surveya,

should be less than the compliance level in each

frequency rangeb.

Interference may occur in the vicinity of

equipment marked with following symbol.

Note: UT is the a.c. mains voltage prior to application of the test level.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from

structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) and land mobile radios, amateur radio, AM and

FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment

due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in

which the Constellation® Vision System is used exceeds the applicable RF compliance level above, the Constellation® Vision

System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,

such as re-orienting or relocating the Constellation® Vision System.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

8065751025 1.11

Constellation® Vision System

Table 1-4 Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the Constellation® Vision System — The Constellation® Vision System is

intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of the Constellation® Vision System can help prevent